Adding voclosporin (VCS) to standard of care improves renal outcomes in patients with active lupus nephritis (LN), according to findings from the AURORA study presented at the live virtual 2020 National Kidney Foundation Spring Clinical Meetings.
Based on the findings, Aurinia Pharmaceuticals, the company developing the drug, plans to file an application seeking FDA approval.
“We are pleased to report that the patients who received voclosporin were 2.65 times more likely to meet the criteria for response based on proteinuria and eGFR [estimated glomerular filtration rate],” lead investigator Keisha L. Gibson, MD, MPH, Associate Professor of Medicine and Pediatrics and Chief of Pediatric Nephrology at the University of North Carolina School of Medicine in Chapel Hill, said in an NKF press statement. “There were no differences in the safety profile between the voclosporin and standard care groups.”
Dr Gibson added, “We know that achieving remission status in lupus kidney disease correlates with good long-term kidney survival and so the results of this study are very encouraging.”
The AURORA study is a global, double-blind, placebo-controlled phase 3 trial that enrolled 357 patients with active LN. Investigators randomly assigned patients to receive voclosporin or placebo in combination with mycophenolate (MMF) and low-dose steroids. The primary end point was renal response (RR) at 52 weeks. They defined RR as a urine protein to creatinine ratio (UPCR) of 0.5 mg/mg or less, eGFR of 60 mL/min/1.73 m2 or higher, or no confirmed 20% or greater decrease in eGFR from baseline, the presence of sustained, low-dose steroids, and no administration of rescue medication.
The RR at 52 weeks was 40.8% for the voclosporin recipients compared with 22.5% for the control arm, a statistically significant difference between the groups, Dr Gibson and her collaborators reported in a late-breaking abstract session. The voclosporin group achieved low protein levels twice as quickly as patients receiving standard of care. An analysis of the median time to a UPCR less than 0.5 mg/mg showed a significant and clinically meaningful benefit in the voclosporin arm compared with the standard of care arm (169 vs 372 days).
Voclosporin was well tolerated, with no unexpected safety issues, according to the investigators. Serious adverse events ere in 20.8% of the voclosporin recipients and 21.3% of control arm. The most common reported SAE was infection, which developed in 10.1% and 11.2% of the voclosporin and controls groups, respectively.
Gibson K, Parikh S, Sexena A, et al. AURORA phase 3 trial demonstrates voclosporin statistical superiority over standard of care in lupus nephritis (LN). Data presented at the National Kidney Foundation’s virtual 2020 Spring Clinical Meetings held March 25 to 29. ePoster 407.
This article originally appeared on Renal and Urology News